Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty

Not Applicable

Recruiting

• Conditions: Osteoarthritis (OA) of the Knee
• Interventions: Diagnostic Test: CT scan bilateral knee; Diagnostic Test: CT scan unilateral knee

• Registration Number: NCT06617338
• Lead Sponsor: University of Louisville

Brief Summary

The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.

The main questions it aims to answer are:

* Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?

* What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.

Participants will:

* Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively

* Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.

* Complete postop questionnaires (PROMs) at the prescribed follow-up intervals

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Study Start: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-04-30
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patient age is 21-89 at time of surgery
2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis
3. Patient's contralateral knee is non-arthritic
4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
5. Patient is able to read and speak English.

Exclusion Criteria

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis
3. Patient is unable to read and speak English
4. History of previous DVT/PE
5. History of stroke, CABG, or A fib
6. Current smoker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Participant receives bilateral knee CT preoperatively	CT scan bilateral knee	The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA
Participant receives unilateral CT of the operative knee preoperatively	CT scan unilateral knee	The P.I. will use the traditional method to obtain target alignment for RA-TKA.

Primary Outcome Measures

Name	Time	Method
Overall Satisfaction	1-year postoperatively	Overall Satisfaction with TKA using a Likert scale
Pain VAS	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively	Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)
KOOS JR	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively	KOOS JR questionnaire
Forgotten Joint Score	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively	FJS-12 questionnaire
PROMIS-10 Mental and Physical Health scores	preoperatively and 1-year postoperatively	PROMIS-10 Global Health questionnaire
Incidence of revision TKA	1 year postop	postoperative complication requiring a revision total knee arthroplasty
non-revision complication	1 year postop	postoperative complication requiring a non-revision procedure

Secondary Outcome Measures

Name	Time	Method
Active ROM	preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively	Active knee range of motion: active extension, active flexion

Trial Locations

Locations (1)

UofL Health; 🇺🇸 Louisville, Kentucky, United States